EVOS 71158092Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556692769), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING SURGERY THE EVOS DVR SYSTEM USED DRILL THAT HAS LASER LINES ON IT. IT WAS MENTIONED THAT THESE LINES ARE VERY SMALL AND THAT SYNTHES (COMPETITOR DEVICE) HAS A OPTION FOR A DEPTH GAUGE OVER THE DRILL. IT WAS MENTIONED THAT THIS WOULD BE SPECIFICALLY HELPFUL TO HAVE AS THE LASER LINES ARE FAR TO SMALL TO READ OFF THE DRILL BIT. IT IS UNKNOWN IF THERE WAS A DELAY IN THE CASE. NO INJURY OR INTERVENTION REPORTED. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10584880 ↗